FDA 510(k)

POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES

K-Number: K092160 · 2009-11-27

ApplicantComfort Rubber Gloves Ind. Sdn. Bhd.

Decision Date2009-11-27

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Comfort Rubber Gloves Ind. Sdn. Bhd.. It received FDA 510(k) clearance on 2009-11-27 under 510(k) number K092160. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES?

POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2009-11-27. The listed applicant is Comfort Rubber Gloves Ind. Sdn. Bhd.. The 510(k) number is K092160.

When did POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES receive FDA 510(k) clearance?

POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES received FDA 510(k) clearance on 2009-11-27, under 510(k) number K092160.

Who is the listed applicant for POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES?

The FDA 510(k) record lists Comfort Rubber Gloves Ind. Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES?

The FDA product code for POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES is LZA.

Related Clinical Trials

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Other records listing Comfort Rubber Gloves Ind. Sdn. Bhd. as applicant

K083624POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES

Related Devices (Code: LZA)

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealth K260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.